Mesobuthus tamulus (Indian Red Scorpion) sting is a severe but neglected health issue in India. The accomplishment of in-patient scorpion sting management is highly dependent on the safety, efficacy, and homogeneity of scorpion antivenom preparation. Therefore, in this study, the above qualities of commercial anti-scorpion antivenoms manufactured in India were assessed by in vitro laboratory analyses. Biophysical characterization of venom by sodium dodecyl sulfate-polyacrylamide gel electrophoresis, size exclusion chromatography, and proteomics analysis demonstrated that anti-scorpion antivenoms (ASAs) mostly contain F(ab')2 molecules with a trace amount of undigested immunoglobulin (Ig) G. The physicochemical characterization, electron microscopy, and dynamic light scattering studies revealed that ASAs were prepared according to the guidelines of World Health Organization (WHO), and were devoid of aggregate content and virus particles. ASAs did not show IgE contamination and bacterial endotoxin but demonstrated moderate complement activation properties, which may have adverse effects in treated patients. Spectrofluorometric and atomic force microscopy analyses showed poor binding of venom with commercial ASAs. The percent of antibodies raised against the venom toxins in commercial ASAs was determined at the range of 5.3-6.3%, which is a reason for their poor efficacy. This study advocates the importance of in vitro laboratory analyses for assessing commercial antivenom's quality and safety parameters before their pre-clinical research and clinical use to treat Indian red scorpion sting.
Keywords: Adverse reaction; Anti-scorpion antivenom; Anti-scorpion immunoglobulin; Antivenom quality assessment; LC-MS/MS analysis.
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